NCT05807256 Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
| NCT ID | NCT05807256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Rheumatic Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-05-04 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-05-04 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Systemic rheumatological diseases often occur in young women of childbearing age and can therefore impact fertility. There are diseases, such as arthritis, which present no contraindication to assisted reproductive techniques (ARTs), because there is no influence on the disease itself if the disease activity at conception is stable. On the other hand, patients suffering from connective tissue diseases, primarily Systemic Lupus Erythematosus (SLE) and patients suffering from primary or SLE-related Anti-Phospholipid Antibody Syndrome (APS), deserve more targeted therapies both in the context of ARTs and in the ensuing pregnancy. To evaluate the response to ARTs in patients with systemic rheumatological diseases, both in terms of reactivation of the underlying pathology and in terms of ARTs outcome.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with systemic immunoreumatologic disease such as SLE, APS, RA, SpA, SclS, SS, PM-DM, vasculitis * patients who have performed one or more PMAs between January 2000 and April 2021 * patients who had their last follow-up by February 2022 Exclusion Criteria: * Patients diagnosed with only one organ autoimmunity (e.g., diabetes mellitus I, thyroiditis of Hashimoto's, celiac disease or chronic inflammatory bowel disease in the absence of systemic disease associated); * patients with severe renal failure, significant pulmonary hypertension or cardiomyopathy severe.
Contact & Investigator
Patrizia Rovere Querini, PhD, MD
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT05807256 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807256 currently recruiting?
Yes, NCT05807256 is actively recruiting participants. Contact the research team at rovere.patrizia@hsr.it for enrollment information.
Where is the NCT05807256 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05807256 clinical trial?
NCT05807256 is sponsored by IRCCS San Raffaele. The principal investigator is Patrizia Rovere Querini, PhD, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 500 participants.